Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report

Chronic Pain Clinical Trial

Official title:

Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04549818
• Other study ID #: SECI2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: December 10, 2021

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age, 18-70

• Pain localized to the pelvic and perineal region

• The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer

• The intensity of pain assessed by VAS (visual analogue pain scale) > 7

• Importantly, the included participants should gain > 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root

Exclusion Criteria:

• Coagulopathy

• Infection at site of maneuver

• Abnormal Psychological behavior that interfere with integrity of obtained data

Related Conditions & MeSH terms

• Cancer Pain
• Chronic Pain
• Pelvic Neoplasms

Intervention

Device:
• sacral neuromodulation
Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of intensity of pain	The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain	The outcome will be measured at day 15 postoperatively.